It is believed that the mammalian immune system plays a significant role in preventing and retarding malignancies. More specifically, it is believed that a subset of lymphocytes known as natural killer (NK) cells scavenge cancer cells from the body, thereby preventing or retarding their proliferation.
It has been observed that pathological conditions characterized by reduced immune system response may also be accompanied by reduced NK cell activity. Further, such conditions may be accompanied by increased tendency toward the development of malignancies. For example, Kaposi's sarcoma has a greatly increased incidence among person suffering from impaired immune systems, as in acquired immune deficiency syndrome (AIDS) and AIDS-related complex (ARC). Researchers have observed decreased NK activity in some of these patients, along with other indicia of decreased immune system response.
The inventor has described in U.S. Pat. Nos. 4,468,379 and 4,616,079, and in various pending patent applications (Ser. No. 813,632, now U.S. Pat. No. 4,699,898, and 902,683, now abandoned) the discovery of biological materials termed "immunomodulators" or "modulators of the immune system," which are capable of modulating the speed and/or intensity of immune system response. A subset of these immunomodulators are "immunoamplifiers" or "amplifiers," which are capable of increasing the speed and/or intensity of immune system response. As explained in the cited patent and patent applications, these materials are distinguished from previously described "transfer factors," which are materials said to have the capability of transferring from a donor to a donee an immune response to a specific antigen, even though the donee has not previously been exposed to that particular antigen. In contrast, amplifiers are not specific to particular antigens and operate more generally (non-specifically). Further, amplifiers increase immune system response only to antigens to which the donee has previously been or is concurrently exposed, and they do not transfer an immune system response to an antigen to which the donee has yet to be exposed.
As described in the cited patent and patent applications, amplifiers may be extracted from human lymphocyte samples, and are relatively low M.W. materials that are elutable by HPLC using various solvent and gradient systems. Analytic tests suggest that active ingredients of the "Beta" amplifier are the dipeptide TG and the tripeptide TGG and/or their derivatives (see '683 patent application). The inventor has discovered that, when appropriately purified, commercially available TG and TGG chemical can produce substantial amplifier effects. The inventor hypothesizes that mammalian immune systems have evolved derivatives of the enkephalins as a material for modulating immune system response and for maintaining its homeostasis.
The '683 patent application also describes purification of Beta-1.0 material into components designated Beta-1.11 and Beta-1.12, amino acid residue analysis of said components as TG and TGG, and methods of modifying the TG and TGG molecules to provide derivatives that are more highly resistant to hydrolysis or enzymatic degradation.